van Meerten E, Muller K, Tilanus H W, Siersema P D, Eijkenboom W M H, van Dekken H, Tran T C K, van der Gaast A
Department of Medical Oncology, Erasmus MC -- University Medical Centre Rotterdam, The Netherlands.
Br J Cancer. 2006 May 22;94(10):1389-94. doi: 10.1038/sj.bjc.6603134.
This study was performed to assess the efficacy and safety of preoperative chemoradiation consisting of carboplatin and paclitaxel and concurrent radiotherapy for patients with resectable (T2-3N0-1M0) oesophageal cancer. Treatment consisted of paclitaxel 50 mg m(-2) and carboplatin AUC=2 on days 1, 8, 15, 22 and 29 and concurrent radiotherapy (41.4 Gy in 23 fractions, 5 days per week), followed by oesophagectomy. All 54 entered patients completed the chemoradiation without delay or dose-reduction. Grade 3-4 toxicities were: neutropaenia 15%, thrombocytopaenia 2%, and oesophagitis 7.5%. After completion of the chemoradiotherapy 63% had a major endoscopical response. Fifty-two patients (96%) underwent a resection. The postoperative mortality rate was 7.7%. All patients had an R0-resection. The pathological complete response rate was 25%, and an additional 36.5% had less than 10% vital residual tumour cells. At a median follow-up of 23.2 months, the median survival time has not yet been reached. The probability of disease-free survival after 30 months was 60%. In conclusion, weekly neoadjuvant paclitaxel and carboplatin with concurrent radiotherapy is a very tolerable regimen and can be given on an outpatient basis. It achieves considerable down staging and a subsequent 100% radical resection rate in this series. A phase III trial with this regimen is now ongoing.
本研究旨在评估术前以卡铂和紫杉醇组成的化疗联合同期放疗对可切除（T2-3N0-1M0）食管癌患者的疗效和安全性。治疗方案为在第1、8、15、22和29天给予紫杉醇50mg/m²和卡铂AUC=2，并同期放疗（23次分割，共41.4Gy，每周5天），随后进行食管切除术。所有54例入组患者均顺利完成放化疗，未出现延迟或剂量减少的情况。3-4级毒性反应包括：中性粒细胞减少15%、血小板减少2%、食管炎7.5%。放化疗完成后，63%的患者在内镜检查中有显著反应。52例患者（96%）接受了手术切除。术后死亡率为7.7%。所有患者均实现了R0切除。病理完全缓解率为25%，另外36.5%的患者存活的残余肿瘤细胞少于10%。中位随访23.2个月时，中位生存时间尚未达到。30个月时无病生存概率为60%。总之，每周新辅助紫杉醇和卡铂联合同期放疗是一种耐受性良好的方案，可在门诊进行。在本系列研究中，该方案实现了显著的降期，并随后达到了100%的根治性切除率。目前正在进行该方案的III期试验。
